Quality Assurance Specialist/Senior Specialist
QUALITY ASSURANCE SPECIALIST / SENIOR SPECIALIST
Adicet Bio is seeking an initiative-taking and experienced Quality Assurance Specialist/Sr. Specialist joining our Quality organization. As the Quality Assurance Specialist, you are responsible to provide quality oversight of Adicet Bio’s clinical manufacturing activities and be able to support and collaborate within Quality organization and across all GMP operational functions including Facilities, Manufacturing, and Quality Control.
You must have strong attention to details and be able to work independently to perform incoming raw materials inspection and release, and to assess, evaluate, and review operations on the floor against current Good Manufacturing Practices (cGMPs), to assure real-time observation of activities and to provide guidance to all GMP areas to ensure compliance with all applicable regulations and Adicet’s policies and procedures. You will timely assist in issue identification and resolution with proper and timely documentation.
This opportunity is located at 1000 Bridge Pkwy in Redwood city, California. You will report to Director, QA GMP Ops.
Key responsibilities:
- Perform Quality oversight activities include but not limited to, raw material quality incoming inspection and release, manufacturing line clearance / changeover walkthrough activities, batch record review and release activities, and any cGMP relevant documentation.
- Review, assess, and approve impact and risk assessments related to changes to materials, equipment, procedures, manufacturing processes, test methods, etc.
- Work constructively with cross-functional departments for timely resolution of quality issues.
- Review, assess, and approve non-conformances/deviations, and CAPAs; work with functional groups to determine root causes for process issues related to products, materials, equipment etc.
- Support activities related to corrections, corrective actions, preventive actions, non-conformances, deviations, and to correct and eliminate the potential sources for non-conformances / deviations.
- Implement continuous process improvement efforts as it relates to QA activities for cGMP operations.
- Support in tracking metrics for trending, reporting and Management Review.
- Other duties are required.
Qualifications:
- BS preferred or related experience in life sciences including biology, immunology, biochemistry, process engineering or a similar biological science.
- Minimum of five (5) years in a Quality, Quality Assurance, or related role within the biotech/pharmaceutical and/or cell/gene therapy industries.
- Requires a minimum of two (2) year of experience managing projects and priorities within complex matrix organizations.
- Demonstrated diligent and productive work ethic in a start-up environment strongly preferred.
- Independent decision-making capability and ability to think conceptually and understand impact of decisions critical.
- Possesses strong conflict resolution and negotiation skills.
- Working knowledge of phase-appropriate clinical and commercial expectations.
- Working Knowledge of conducting risk assessment, root cause analyses, and impact analyses.
- Multitasker, collaborative, analytical, organized, meticulous & initiative-taking.
- Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems.
- Exceptional communication and people skills.
Benefits:
Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.
Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose.
Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.